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Details for Patent: 5,674,858

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Details for Patent: 5,674,858

Title: Medicaments for treating gastrointestinal disorders
Abstract:The use is described of both (i) ranitidine bismuth citrate and (ii) one or more Helicobacter pylori-inhibiting antibiotics in treating or preventing gastrointestinal disorders. Pharmaceutical compositions containing both (i) and (ii) and methods for the preparation of pharmaceutical compositions containing (i) and (ii) are also described.
Inventor(s): McColm; Andrew Alexander (Greenford, GB3)
Assignee: Glaxo Group Limited (GB3)
Filing Date:Jun 05, 1995
Application Number:08/462,586
Claims:1. A method for treating gastrointestinal disorders caused or mediated by H. pylori infections in humans or animals which comprises administering to a human or animal in need thereof an amount of ranitidine bismuth citrate effective against H. pylori in combination with a pharmaceutically acceptable carrier, one antibacterial agent selected from the group consisting of metronidazole, amoxycillin and clarithromycin in an amount effective against H. pylori in combination with a pharmaceutically acceptable carrier, and one antibiotic selected from the group consisting of tinidazole, tetracyclin, doxycyclin, minocyclin, ampicillin, mezlocillin, cefachlor, cefadroxil, cephradine, cefuroxime, cefuroxime axetil, cephalexin, cefpodoxime proxetil, ceftazidime, ceftriaxone, imipenem, meropenem, paromonycin, erythromycin, azithromycin, clidamycin, ofloxacin, ciprofloxacin, pefloxacin, norfloxacin, rifampicin and nitrofurantoin, in combination with a pharmaceutically acceptable carrier, said ranitidine bismuth citrate and said antibacterial agent being administered in relative amounts such that it provides a greater than additive effect, said administration being concurrent or nonconcurrent.

2. A method according to claim 1 wherein the gastrointestinal disorder treated is a non-ulcerative one.

3. A method according to claim 1 wherein the gastrointestinal disorder treated is gastritis, non-ulcer dyspepsia, esophagal reflux disease or gastric motility disorder.

4. A method according to claim 1 wherein the gastrointestinal disorder treated is peptic ulcer disease.

5. A method according to claim 1 wherein from 150 mg to 1.5 g of ranitidine bismuth citrate is administered one to four times per day.

6. A method according to claim 5 wherein from 200 to 800 mg of ranitidine bismuth citrate is administered one to four times per day.

7. A method according to claim 1 wherein the administration is concurrent.

8. A method according to claim 1 wherein the administration is nonconcurrent.

9. A method according to claim 1 wherein the antibacterial agent is metronidazole and the antibiotic is tetracyclin.

10. A method according to claim 1 wherein the antibacterial agent is clarithromycin and the antibiotic is tetracyclin.

11. A method according to claim 1 wherein the antibacterial agent is metronidazole and the antibiotic is cefuroxime.

12. A method according to claim 1 wherein the administration is oral.

13. A pharmaceutical composition useful for treating gastrointestinal disorders caused or mediated by H. pylori infections in humans and animals which comprises an amount of ranitidine bismuth citrate effective against H. pylori, one antibacterial agent selected from the group consisting of metronidazole, amoxycillin and clarithromycin in an amount effective against H. pylori, one antibacterial agent selected from the group consisting of metronidazole, amoxycillin and clarithromycin in an amount effective against H. pylori in combination with a pharmaceutically acceptable carrier, and one antibiotic selected from the group consisting of tinidazole, tetracyclin, doxycyclin, minocyclin, ampicillin, mezlocillin, cefachlor, cefadroxil, cephradine, cefuroxime, cefuroxime axetil, cephalexin, cefpodoxime proxetil, ceftazidime, ceftriaxone, imipenem, meropenem, paromonycin, erythromycin, azithromycin, clidamycin, ofloxacin, ciprofloxacin, pefloxacin, norfloxacin, rifampicin and nitrofurantoin, in combination with a pharmaceutically acceptable carrier, said ranitidine bismuth citrate and said antibacterial agent being present in relative amounts such that the combination provides a greater than additive effect.

14. A pharmaceutical composition according to claim 13 wherein said gastrointestinal disorder is a nonulcerative disorder.

15. A pharmaceutical composition according to claim 13 wherein said gastrointestinal disorder is gastritis, nonulcer dyspepsia, esophageal reflux disease or gastric motility disorder.

16. A pharmaceutical composition according to claim 13 wherein said gastrointestinal disorder is peptic ulcer disease.

17. A pharmaceutical composition according to claim 13 in unit dosage form comprising about 15 mg to 1.5 g of ranitidine bismuth citrate.

18. A pharmaceutical composition according to claim 13 in unit dosage form comprising from about 200 to 800 mg of ranitidine bismuth citrate.

19. A pharmaceutical composition according to claim 13 which is formulated for oral administration.

20. A pharmaceutical composition according to claim 13 wherein the antibacterial agent is metronidazole and the antibiotic is tetracyclin.

21. A pharmaceutical composition according to claim 13 wherein the antibacterial agent is clarithromycin and the antibiotic is tetracyclin.

22. A pharmaceutical composition according to claim 13 wherein the antibacterial agent is metronidazole and the antibiotic is cefuroxime.
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